Archive | Regulatory

FDA Grants Fast Track Designation to CMP-001 Combination in Advanced Melanoma

The FDA has granted Fast Track designation to CMP-001 in combination with nivolumab (Opdivo) plus ipilimumab (Yervoy), which will undergo clinical trial development both as a potential extender of time to disease relapse as an initial treatment of patients with unresectable stage III or stage IV melanoma, as well as to improve the overall tumor […]

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Posted in Melanoma News, Regulatory, Publications

Polynoma Receives FDA Fast Track Designation for its Melanoma Cancer Vaccine Seviprotimut-L

Polynoma LLC, announces that the U.S. Food and Drug Administration (FDA) has granted its application for Fast Track designation of seviprotimut-L.

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Posted in Melanoma News, Regulatory, Publications

NKTR-214 with Opdivo Earns FDA’s Breakthrough Therapy Designation for Advanced Melanoma

The U.S. Food and Drug Administration (FDA) has granted breakthrough therapy designation for a combination of the potential therapy NKTR-214 with Opdivo (nivolumab) for untreated melanoma patients with either metastatic disease or who are unable to undergo surgery.

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Posted in Melanoma News, Regulatory, Publications

Bempegaldesleukin Plus Nivolumab Granted Breakthrough Designation in Melanoma by the FDA

The combination of bempegaldesleukin (NKTR-214) and nivolumab (Opdivo) was granted a breakthrough therapy designation by the FDA for the treatment of patients with previously untreated unresectable or metastatic melanoma.

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Posted in Melanoma News, Regulatory, Publications